Guilin Woodpecker Medical Instrument Fi-G Instruction Manual Download Page 11 | Manualshive

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Guilin Woodpecker Medical Instrument Fi-G Instruction Manual Download Page 11

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5. Please do not mix the device with hazardous articles during

transport.

6. Please avoid the device from sun, rain, and snow during transport.

2 Standard icons

Product serial number

Follow Instructions for Use

Manufacturer

Date of manufacture

Type B applied part

Class II device

Power switch

Ordinary equipment

Used indoor only

Caution, hot surface

Can be autoclaved

DC 15V

Rectilinear motion

Device complies with

WEEE directive

Attention! Please refer to the accompanying documents.

Humidity limit for storage: 10% ~ 93%

Atmospheric pressure for storage: 70kPa ~ 106kPa

Temperature limit for storage: -20℃ ~ +55℃

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Summary of Contents for Fi-G

Page 1: ......

Page 2: ...tion and disassembly method of accessories 10 5 Operation method 11 6 Charging instruction 13 7 Safety precautions 14 8 Cleaning Disinfection Sterilization and Maintenance 14 9 Troubleshooting 22 10 After sales service 23 11 Environment protection 24 12 EMC Declaration of comformity 24 13 Statement 28 ...

Page 3: ...ty requirements are classed under the following indications Danger always referred to personal injury warning referred to possible damage to property 1 Product introduction 1 1 Intended use Heat up and soften gutta percha and fill the gutta percha into the root canal after preparation And the applied part is Gutta Percha Injecting Needle 1 2 Diagram of components and control buttons The Fi G is eq...

Page 4: ...Power adapter plug 14 Power adapter unit 15 Connecting hole for power supply 16 Trigger 1 ON OFF button a In the OFF state long press the left or right ON OFF button can turn on the power After the power is turned on the left and right displays will be lit at the same time b In the ON state long press the left or right ON OFF button can turn off the power Note If there is no operation for 10 minut...

Page 5: ... switch all the time 4 Battery level The actual power of the battery is displayed in real time on the screen When the battery is fully charged the power of the OLED display is displayed as five grids When the battery level is one grid it indicates that the battery is low and needs to be charged in time When the battery level is displayed as a space it indicates that the battery is very low and nee...

Page 6: ...ector of the charging base When the Hot Melting and Filling Instrument is properly connected to the charging base the LED charging indicator on the base will be on constantly If the LED is flashing or not lit please check all the cables carefully There are charging status indicators on the charging base When the Hot Melting and Filling Instrument is not placed on the charging base the indicator wi...

Page 7: ...ur company to prevent the needle from falling off or the gutta percha leakage during use But do not to screw too tight Here we provide a variety of needles with different sizes Please refer to Table 2 and the needles can be pre bent depending on the application Note Store unused Gutta Percha Injecting Needles in a sealed environment as the Gutta Percha Injecting Needle are made of silver and may d...

Page 8: ...ercha Injecting Needle and its connection to Hot Melting and Filling Instrument After tighten the Gutta Percha Injecting Needle the needle can be bent to any suitable angle with wrench Do not use other instruments to pre bend the needle other than the wrench provided by manufacturers 11 Cleaning brush To remove remaining material from inside the heating or loading slot set the temperature to 150 e...

Page 9: ...hand operation b Cordless design for Hot Melting and Filling Instrument effectively broadens the operation space c Sensitive temperature control simple display and convenient operation Press temperature setting button to set suitable working temperature d Four preset temperatures are for option 150 180 200 230 e Safe protecting system If there is no operation for 10 minutes the Hot Melting and Fil...

Page 10: ...argeable battery 2000mAh Heater Rating 10W 1 7 Environmental parameters Working condition Temperature 5 40 Humidity 30 75 Air pressure 70kPa 106kPa 1 8 Storage and transport 1 The device should be handled carefully and lightly Be sure that it is far from the vibration and is installed or kept in a cool dry and ventilated place 2 Do not store the device together with the articles that are combustib...

Page 11: ...ons for Use Manufacturer Date of manufacture Type B applied part Class II device Power switch Ordinary equipment Used indoor only Caution hot surface Can be autoclaved DC 15V Rectilinear motion Device complies with WEEE directive Attention Please refer to the accompanying documents Humidity limit for storage 10 93 Atmospheric pressure for storage 70kPa 106kPa Temperature limit for storage 20 55 ...

Page 12: ...and pre bent of Gutta Percha Injecting Needle Note In order to prevent from scalding when replace the Gutta Percha Injecting Needle please first power off and wait for 5 minutes Only after the heating chamber cools down the replacement can start 1 Power off the device and wait for 5 minutes until the Hot Melting and Filling Instrument cools down And then use wrench to disassemble the needle in cou...

Page 13: ...ember to install the Thermal Protector Cap to prevent users or patients from scalding 1 Choose Gutta Percha Injecting Needle Choose suitable Gutta Percha Injecting Needle 20ga 23ga or 25ga according to the situation of patient And tighten the Gutta Percha Injecting Needle and handpiece Note not too tight When using the Gutta Percha Injecting Needle can rotate to suitable angle within the range of ...

Page 14: ...displays the needed temperature value After each press the temperature will change once in the sequence of 150 180 200 230 And it will back to 150 when you press the button while at 230 During operation please refer to Table 1 Recommended temperature setting to set suitable temperature One second after setting suitable temperature the display screen will automatically skip to display the actual he...

Page 15: ...e the Hot Melting and Filling Instrument 6 After operation the remaining materials in the heating chamber must be cleaned and the relevant accessories must be cleaned disinfected and sterilized For details see Chapter 8 6 Charging instruction 6 1 Use corresponding charging base for charging Connect the power adapter to the charging base and connect to power supply And then correctly place the Hot ...

Page 16: ...irst power off and wait for 5 minutes Five minutes later if the Hot Melting and Filling Instrument totally cools down replace the needle 7 The needle must be correctly installed to prevent from falling off or gutta percha leakage during operation 8 Do not use excessive force when pre bending the injection needle to prevent the needle from breaking When the needle is bent or worn the gutta percha f...

Page 17: ...e only sufficiently validated equipment and product specific procedures are used for cleaning disinfection and sterilization and that the validated parameters are adhered to during every cycle Please also observe the applicable legal requirements in your country as well as the hygiene regulations of the hospital or clinic especially with regard to the additional requirements for the inactivation o...

Page 18: ...eaning should be performed no later than 24 hours after the operation The cleaning can be divided into automated cleaning and manual cleaning Automated cleaning is preferred if conditions permit 8 3 1 Automated cleaning The cleaner is proved to be valid by CE certificationin accordance with EN ISO 15883 The cleaning procedure is suitable for the product and the irrigating period is sufficient It i...

Page 19: ...the product repeatedly if necessary refer to section Drying The intrinsic suitability of the product for effective cleaning and disinfection using the above automated cleaning and disinfection procedures was verified by a certified facility Notes a Before use you must carefully read the operating instructions provided by the equipment manufacturer to familiarize yourself with the disinfection proc...

Page 20: ...e cloth on the flat table point the product against the white paper white cloth and then dry the product with filtered dry compressed air maximum pressure 3 bar Until no liquid is sprayed onto the white paper white cloth the product drying is completed 2 It can also be dried directly in a medical drying cabinet or oven The recommended drying temperature is 80 120 and the time should be 15 40 minut...

Page 21: ...s fractional pre vacuum procedure for sterilization and other sterilization procedures are prohibited 1 The steam sterilizer complies with EN13060 or is certified according to EN 285 to comply with EN ISO 17665 2 The highest sterilization temperature is 138 C 3 The sterilization time is at least 4 minutes at a temperature of 132 134 and a pressure of 2 0 bar 2 3 bars 4 Allow a maximum sterilizatio...

Page 22: ...nt should be clean and must be disinfected regularly b Product storage must be batched and marked and recorded 8 10 Transportation 1 Prevent excessive shock and vibration during transportation and handle with care 2 It should not be mixed with dangerous goods during transportation 3 Avoid exposure to sun or rain or snow during transportation 8 11 The cleaning and disinfection of Backfilling Handpi...

Page 23: ... 3 times 8 12 Daily maintenance When the device is not used please turn off the power and unplug the power supply plug If the Hot Melting and Filling Instrument is in a low battery state for a long time the service life of battery will be shortened Please charge it in time if the battery level is low When the device is not used please charge it for 1 hour once a month Warning Equipment and all acc...

Page 24: ...nufacturer Gutta percha cannot flow out from the needle 1 The push ram has been pushed to the end indicating that the gutta percha has run out 2 The pushing ram seal ring is damaged 3 The needle is damaged and blocked 1 Pull back the pushing ram and load a new gutta percha stick 2 Replace the pushing ram 3 Replace the needle Automatic shutdown If there is no operation for 10 minutes the device wil...

Page 25: ...se do not push or pull the pushing ram vigorously When the gutta percha is heated up to the preset temperature the pushing ram should be pushed by pulling the trigger for multiple times If the pushing ram does not move try to push it manually with a slight force and try to pull the trigger 2 Please refer to the recommended temperature to set the preset temperature 3 To remove all remaining materia...

Page 26: ...al Description Concerning Electromagnetic Emission Table 1 Declaration electromagnetic emissions Guidance and manufacturer s declaration electromagnetic emissions The model Fi G is intended for use in the electromagnetic environment specified below The customer or the user of the model Fi G should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment g...

Page 27: ...put output lines 2kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge lEC 61000 4 5 0 5 1kV line to line 0 5 1 2kV line to earth 0 5 1kV line to line 0 5 1 2kV line to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input li...

Page 28: ...or to application of the test level Table 3 Guidance Declaration electromagnetic immunity concerning Conducted RF Radiated RF Guidance Declaration Electromagnetic immunity The model Fi G is intended for use in the electromagnetic environment specified below The customer or the user of the models Fi G should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance...

Page 29: ...rference may occur In the vicinity of equipment marked with the following symbol NOTE I At 80 MHz end 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless tel...

Page 30: ... 800MHz to 2 7GHz d 2 3 P1 2 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W accordable to the ...

Page 31: ...ZMN SM 038 V1 1 20200306 ...

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